NCT04602559

Exploratory Study : to Evaluate the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema

Exploratory Study to Evaluate the Clinical Benefits of Wearing the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema : OLYMPY Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Thuasne · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Lymphedema (LO) is a chronic and disabling condition that affects quality of life. This pathology has a physical, psychological, social and professional impact. Pelvic or genital lymphedema (LP/LG) is the result of a dysfunction of the lymphatic system in the genital area that can occur following surgery, radiation therapy, tumor, infections affecting the inguinal lymph nodes or related lymphatic pathways (secondary LP/LG). Urogenital cancers are the major cause of secondary LP/LG. It is difficult to have an accurate estimate of the prevalence of LP/LG. LP/LG can be painful, the edema very bulky and disharmonious. The patient is facing with significant physical and psychological difficulties. The volume of the lymphedema can be important, causing discomfort, rubbing when walking or during physical activities, disrupting daily life and may constitute a major handicap.

Detailed description

Currently, there is no reference treatment which is validated for these lymphedemas, and few recommendations from the competent authorities or learned societies are available. There is no solution available on the market which covers all the needs and expectations of patients and healthcare professionals. The Panty MOBIDERM is a standard pelvic compressive orthosis that should promote lymphatic drainage, then reduce the volume of edema, and contributing to an overall improvement in the patients' quality of life.

Conditions

• Lymphedema of Genitalia

Interventions

Type	Name	Description
DEVICE	MOBIDERM Panty group	In the MOBIDERM Panty group, patients wear the MOBIDERM Panty during day and night for 3 months with the possibility to add the PAD. The protocol includes 3 visits. Visit 1 at day 0, corresponding to the inclusion visit, includes device delivery and some clinical evaluations (clinical examination, characteristics of lymphedema, self questionnaires, pain assessment, perimeter data). Visit 2 at 30 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance). Visit 3 at 90 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance).

Timeline

• Start date: 2020-12-03
• Primary completion: 2021-07-09
• Completion: 2021-07-09
• First posted: 2020-10-26
• Last updated: 2022-01-26

Locations

3 sites across 1 country: France